Trial Outcomes & Findings for Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma (NCT NCT01626495)
NCT ID: NCT01626495
Last Updated: 2020-03-23
Results Overview
Inclusive of any events that are "possibly", "likely", or "definitely" related to study treatment any time from the first day of study treatment until week 24.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
73 participants
Primary outcome timeframe
24 weeks
Results posted on
2020-03-23
Participant Flow
Participant milestones
| Measure |
CART-19 T Cells
The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.
CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
|
|---|---|
|
Overall Study
STARTED
|
73
|
|
Overall Study
Intervention
|
62
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
CART-19 T Cells
The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.
CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Disease progression
|
27
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Administrative problem
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
New cancer therapy
|
16
|
|
Overall Study
Manufacturing failure
|
1
|
Baseline Characteristics
Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma
Baseline characteristics by cohort
| Measure |
CART-19 T Cells
n=62 Participants
The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.
CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
|
|---|---|
|
Age, Categorical
<=18 years
|
54 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12 Years
STANDARD_DEVIATION 5.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksInclusive of any events that are "possibly", "likely", or "definitely" related to study treatment any time from the first day of study treatment until week 24.
Outcome measures
| Measure |
CART-19 T Cells
n=62 Participants
The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.
CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
|
|---|---|
|
Number of Subjects With Study Related Adverse Events.
|
59 Participants
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
CART-19 T Cells
n=62 Participants
The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.
CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
|
|---|---|
|
The Number of Subjects With a Successful Product Manufactured
|
60 Participants
|
SECONDARY outcome
Timeframe: 4 WeeksComplete remission rate for subjects with Non-CNS3 ALL. National Comprehensive Cancer Network standard response criteria, which define complete remission (CR) as ,5% bone marrow blasts by morphologic determination, with no evidence of extramedullary disease or refractory disease.
Outcome measures
| Measure |
CART-19 T Cells
n=62 Participants
The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.
CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
|
|---|---|
|
Number of Subjects With Complete Remission (CR).
|
16 Participants
|
SECONDARY outcome
Timeframe: 4 WeeksComplete remission rate for subjects with Non-CNS3 ALL. National Comprehensive Cancer Network standard response criteria, which define complete remission (CR) as ,5% bone marrow blasts by morphologic determination, with no evidence of extramedullary disease or refractory disease.
Outcome measures
| Measure |
CART-19 T Cells
n=62 Participants
The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.
CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
|
|---|---|
|
Number of Subjects With Complete Remission With Incomplete Blood Count Recovery (CRi).
|
38 Participants
|
Adverse Events
CART-19 T Cells
Serious events: 58 serious events
Other events: 62 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CART-19 T Cells
n=73 participants at risk
The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.
CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
63.0%
46/73 • 2 Years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
8.2%
6/73 • 2 Years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
4.1%
3/73 • 2 Years
|
|
Blood and lymphatic system disorders
Hypofibrinogenaemia
|
1.4%
1/73 • 2 Years
|
|
Cardiac disorders
Left ventricular dysfunction
|
5.5%
4/73 • 2 Years
|
|
Cardiac disorders
Bradycardia
|
1.4%
1/73 • 2 Years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.4%
1/73 • 2 Years
|
|
Eye disorders
Visual impairment
|
1.4%
1/73 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/73 • 2 Years
|
|
Gastrointestinal disorders
Haematochezia
|
1.4%
1/73 • 2 Years
|
|
General disorders
Pyrexia
|
20.5%
15/73 • 2 Years
|
|
General disorders
Vascular stent thrombosis
|
1.4%
1/73 • 2 Years
|
|
Immune system disorders
Cytokine release syndrome
|
71.2%
52/73 • 2 Years
|
|
Immune system disorders
Anaphylactic reaction
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Device related infection
|
6.8%
5/73 • 2 Years
|
|
Infections and infestations
Lung infection
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Staphylococcal infection
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Streptococcal infection
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Varicella zoster virus infection
|
1.4%
1/73 • 2 Years
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.4%
1/73 • 2 Years
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
1.4%
1/73 • 2 Years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.8%
5/73 • 2 Years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
1/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.4%
1/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/73 • 2 Years
|
|
Nervous system disorders
Encephalopathy
|
23.3%
17/73 • 2 Years
|
|
Nervous system disorders
Seizure
|
5.5%
4/73 • 2 Years
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
1.4%
1/73 • 2 Years
|
|
Nervous system disorders
Headache
|
4.1%
3/73 • 2 Years
|
|
Nervous system disorders
Speech disorder
|
1.4%
1/73 • 2 Years
|
|
Psychiatric disorders
Mental status changes
|
1.4%
1/73 • 2 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
6.8%
5/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.7%
10/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
5.5%
4/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
1.4%
1/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
1.4%
1/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.4%
1/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/73 • 2 Years
|
|
Vascular disorders
Hypotension
|
32.9%
24/73 • 2 Years
|
|
Vascular disorders
Capillary leak syndrome
|
13.7%
10/73 • 2 Years
|
|
Blood and lymphatic system disorders
Haemolysis
|
1.4%
1/73 • 2 Years
|
|
Cardiac disorders
Atrial thrombosis
|
1.4%
1/73 • 2 Years
|
|
Endocrine disorders
Adrenal insufficiency
|
1.4%
1/73 • 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
2/73 • 2 Years
|
|
General disorders
Facial pain
|
1.4%
1/73 • 2 Years
|
|
General disorders
Pain
|
4.1%
3/73 • 2 Years
|
|
Infections and infestations
Bk virus infection
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Enterococcal bacteraemia
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Gastroenteritis salmonella
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Klebsiella infection
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Stomatococcal infection
|
1.4%
1/73 • 2 Years
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.4%
1/73 • 2 Years
|
|
Investigations
Weight decreased
|
1.4%
1/73 • 2 Years
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.4%
1/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
1/73 • 2 Years
|
|
Nervous system disorders
Unresponsive to stimuli
|
1.4%
1/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
1/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/73 • 2 Years
|
|
Vascular disorders
Hypertension
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Pyomyositis
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Staphylococcal skin infection
|
1.4%
1/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.4%
1/73 • 2 Years
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/73 • 2 Years
|
|
General disorders
Complication associated with device
|
1.4%
1/73 • 2 Years
|
|
Infections and infestations
Clostridium difficile colitis
|
1.4%
1/73 • 2 Years
|
|
Metabolism and nutrition disorders
Acidosis
|
1.4%
1/73 • 2 Years
|
|
Nervous system disorders
Central nervous system haemorrhage
|
1.4%
1/73 • 2 Years
|
|
Nervous system disorders
Facial paresis
|
1.4%
1/73 • 2 Years
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/73 • 2 Years
|
Other adverse events
| Measure |
CART-19 T Cells
n=73 participants at risk
The subject's thawed T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). The T cells will be infused over 10-15 minutes on days Days 0, and 1. Day 14 is tentative based on response.
CART-19: Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.7%
10/73 • 2 Years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
68.5%
50/73 • 2 Years
|
|
Blood and lymphatic system disorders
Splenomegaly
|
6.8%
5/73 • 2 Years
|
|
Cardiac disorders
Sinus tachycardia
|
16.4%
12/73 • 2 Years
|
|
Cardiac disorders
Tachycardia
|
41.1%
30/73 • 2 Years
|
|
Eye disorders
Conjunctival haemorrhage
|
5.5%
4/73 • 2 Years
|
|
Eye disorders
Diplopia
|
5.5%
4/73 • 2 Years
|
|
Eye disorders
Photophobia
|
5.5%
4/73 • 2 Years
|
|
Gastrointestinal disorders
Abdominal pain
|
28.8%
21/73 • 2 Years
|
|
Gastrointestinal disorders
Constipation
|
13.7%
10/73 • 2 Years
|
|
Gastrointestinal disorders
Diarrhoea
|
47.9%
35/73 • 2 Years
|
|
Gastrointestinal disorders
Haematochezia
|
5.5%
4/73 • 2 Years
|
|
Gastrointestinal disorders
Nausea
|
61.6%
45/73 • 2 Years
|
|
Gastrointestinal disorders
Vomiting
|
65.8%
48/73 • 2 Years
|
|
General disorders
Chills
|
37.0%
27/73 • 2 Years
|
|
General disorders
Fatigue
|
39.7%
29/73 • 2 Years
|
|
General disorders
Pain
|
38.4%
28/73 • 2 Years
|
|
General disorders
Pyrexia
|
20.5%
15/73 • 2 Years
|
|
Hepatobiliary disorders
Hepatomegaly
|
6.8%
5/73 • 2 Years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
17.8%
13/73 • 2 Years
|
|
Immune system disorders
Cytokine release syndrome
|
6.8%
5/73 • 2 Years
|
|
Immune system disorders
Hypogammaglobulinaemia
|
57.5%
42/73 • 2 Years
|
|
Infections and infestations
Otitis media
|
8.2%
6/73 • 2 Years
|
|
Infections and infestations
Pneumonia
|
5.5%
4/73 • 2 Years
|
|
Infections and infestations
Respiratory syncytial virus infection
|
5.5%
4/73 • 2 Years
|
|
Infections and infestations
Sinusitis
|
13.7%
10/73 • 2 Years
|
|
Infections and infestations
Upper respiratory tract infection
|
15.1%
11/73 • 2 Years
|
|
Infections and infestations
Urinary tract infection
|
5.5%
4/73 • 2 Years
|
|
Injury, poisoning and procedural complications
Contusion
|
9.6%
7/73 • 2 Years
|
|
Injury, poisoning and procedural complications
Fall
|
5.5%
4/73 • 2 Years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.5%
4/73 • 2 Years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
15.1%
11/73 • 2 Years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
30.1%
22/73 • 2 Years
|
|
Investigations
Alanine aminotransferase increased
|
61.6%
45/73 • 2 Years
|
|
Investigations
Aspartate aminotransferase increased
|
63.0%
46/73 • 2 Years
|
|
Investigations
Blood bilirubin increased
|
20.5%
15/73 • 2 Years
|
|
Investigations
Blood creatinine increased
|
31.5%
23/73 • 2 Years
|
|
Investigations
Blood fibrinogen decreased
|
15.1%
11/73 • 2 Years
|
|
Investigations
Blood immunoglobulin A decreased
|
6.8%
5/73 • 2 Years
|
|
Investigations
Blood immunoglobulin M decreased
|
6.8%
5/73 • 2 Years
|
|
Investigations
Blood uric acid increased
|
15.1%
11/73 • 2 Years
|
|
Investigations
Haemoglobin decreased
|
78.1%
57/73 • 2 Years
|
|
Investigations
International normalised ratio increased
|
21.9%
16/73 • 2 Years
|
|
Investigations
Lipase increased
|
5.5%
4/73 • 2 Years
|
|
Investigations
Lymphocyte count decreased
|
8.2%
6/73 • 2 Years
|
|
Investigations
Neutrophil count decreased
|
76.7%
56/73 • 2 Years
|
|
Investigations
Platelet count decreased
|
74.0%
54/73 • 2 Years
|
|
Investigations
Weight decreased
|
6.8%
5/73 • 2 Years
|
|
Investigations
White blood cell count decreased
|
79.5%
58/73 • 2 Years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
58.9%
43/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.6%
7/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
30.1%
22/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
11.0%
8/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.7%
10/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.1%
11/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.2%
6/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.5%
15/73 • 2 Years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
11.0%
8/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.3%
9/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
5/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.2%
14/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.5%
4/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.2%
14/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.5%
4/73 • 2 Years
|
|
Nervous system disorders
Dizziness
|
16.4%
12/73 • 2 Years
|
|
Nervous system disorders
Headache
|
63.0%
46/73 • 2 Years
|
|
Nervous system disorders
Tremor
|
5.5%
4/73 • 2 Years
|
|
Product Issues
Device occlusion
|
5.5%
4/73 • 2 Years
|
|
Psychiatric disorders
Anxiety
|
6.8%
5/73 • 2 Years
|
|
Psychiatric disorders
Confusional state
|
20.5%
15/73 • 2 Years
|
|
Psychiatric disorders
Insomnia
|
11.0%
8/73 • 2 Years
|
|
Renal and urinary disorders
Haematuria
|
5.5%
4/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.9%
35/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
4/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.5%
15/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.3%
9/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.8%
13/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.2%
6/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.2%
6/73 • 2 Years
|
|
Reproductive system and breast disorders
Rhinorrhoea
|
21.9%
16/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
13.7%
10/73 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.5%
4/73 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
12.3%
9/73 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
8.2%
6/73 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.0%
8/73 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
8.2%
6/73 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
11.0%
8/73 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
8.2%
6/73 • 2 Years
|
|
Vascular disorders
Hypertension
|
17.8%
13/73 • 2 Years
|
|
Vascular disorders
Hypotension
|
17.8%
13/73 • 2 Years
|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
3/73 • 2 Years
|
|
Eye disorders
Vision blurred
|
4.1%
3/73 • 2 Years
|
|
Gastrointestinal disorders
Gingival bleeding
|
4.1%
3/73 • 2 Years
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
4.1%
3/73 • 2 Years
|
|
General disorders
Catheter site haemorrhage
|
4.1%
3/73 • 2 Years
|
|
General disorders
Catheter site pain
|
4.1%
3/73 • 2 Years
|
|
General disorders
Complication associated with device
|
4.1%
3/73 • 2 Years
|
|
General disorders
Face oedema
|
4.1%
3/73 • 2 Years
|
|
General disorders
Generalised oedema
|
4.1%
3/73 • 2 Years
|
|
General disorders
Withdrawal syndrome
|
4.1%
3/73 • 2 Years
|
|
Immune system disorders
Seasonal allergy
|
4.1%
3/73 • 2 Years
|
|
Infections and infestations
Clostridium difficile colitis
|
4.1%
3/73 • 2 Years
|
|
Infections and infestations
Escherichia urinary tract infection
|
4.1%
3/73 • 2 Years
|
|
Infections and infestations
Oral candidiasis
|
4.1%
3/73 • 2 Years
|
|
Infections and infestations
Rhinitis
|
4.1%
3/73 • 2 Years
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
4.1%
3/73 • 2 Years
|
|
Investigations
Amylase increased
|
4.1%
3/73 • 2 Years
|
|
Investigations
Prothrombin time prolonged
|
4.1%
3/73 • 2 Years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.1%
3/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
4.1%
3/73 • 2 Years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.1%
3/73 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
4.1%
3/73 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
4.1%
3/73 • 2 Years
|
|
Psychiatric disorders
Depression
|
4.1%
3/73 • 2 Years
|
|
Psychiatric disorders
Irritability
|
4.1%
3/73 • 2 Years
|
|
Renal and urinary disorders
Acute kidney injury
|
4.1%
3/73 • 2 Years
|
|
Renal and urinary disorders
Dysuria
|
4.1%
3/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.1%
3/73 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.1%
3/73 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.1%
3/73 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.1%
3/73 • 2 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place